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Completed

NCT Number: NCT06497439

Efficacy and Safety of Silfamin for Common Cold

This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.

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Key information

Conditions

Common Cold Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sore-throat Stomatognathic Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IMERI Faculty of Medicine, University of Indonesia, Jakarta Pusat, Jakarta Special Capital Region, Indonesia

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About this study

There will be 2 groups of treatment; each group will consist of 30 subjects receiving the following regimens for three days:

Treatment I : 2 tablets of Silfamin 150 mg 2 times daily Treatment II : 2 tablets of Placebo 2 times daily

Eligible subjects will be evaluated for treatment efficacy at 0 hours (just before drug administration), 1 and 2 hours after the first dose. For the next doses, subject will perform a self-assessment for treatment efficacy at 1 and 2 hours after every dosing, and record it in subject's diary.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Otherwise healthy (by anamnesis) men or women aged 18 to 60 years with mild or moderate common cold with or without sore throat (Common cold Score of 1 or 2)
  • Willing to participate in the study by signing the informed consent

Exclusion criteria

  • Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
  • Known hypersensitivity to herbal drugs containing Nigella sativa and/or Phaleria macrocarpa
  • Pregnant or lactating women
  • Have received any analgesic, anti-inflammatory or other common cold preparation within the past 24 hours
  • Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
  • Severe illness, e.g. severe hypertension (> 160/100 mmHg)

Treatment and study plan

Silfamin

Drug

2 tablets of Silfamin 150 mg twice daily

Other names: Herbacold

Placebo tablet of Silfamin

Drug

2 tablets of Silfamin Placebo twice daily

Primary outcomes

  1. Score of common cold and sore throat

    Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days

    Score of common cold and sore throat measured at 0 hours (just before drug administration) for the first dose, 1 and 2 hours after every dosing

  2. VAS score of sore throat

    Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days

    VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing

Secondary outcomes

  1. Adverse events

    Time frame: 1, 2, 3 days

    Number of adverse event, will be observed throughout the study conduct

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Collaborators

  • Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat: Preliminary Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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